An on-going review has concluded that, "it appears increasingly likely that there is an association between varenicline and serious neuropsychiatric symptoms".

Patients and their carers have been warned to:

Tell their doctor about any history of psychiatric illness prior to starting treatment with varenicline

Be alert to and monitor for changes in mood and behaviour including anxiety, nervousness, tension, depressed mood and thinking about or attempting suicide

Immediately report changes in mood and behaviour to their doctor and stop treatment

Be aware that varenicline may cause vivid or strange dreams and may impair the ability to drive or operate heavy machinery

Action: Clinicians should be aware of these safety concerns. Treatment should be stopped immediately if a patient develops neuropsychiatric symptoms. Clinicians should also be aware that these symptoms have developed in some patients after treatment was stopped.